Aurobindo Pharma gets USFDA nod for Levofloxacin injection
New Delhi: Aurobindo Pharma said it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin injection, an anti-infective used in the treatment of bacterial infection in adults.
The approval is for Levofloxacin in 5 per cent Dextrose injection in the strengths of 250 mg/50 ml, 500 mg/100 ml, and 750 mg/150 ml, single use containers, Aurobindo Pharma said in a BSE filing.
The product is expected to be launched in the first quarter of 2016-17, it added.
The approved product is bio-equivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin (Levaquin in 5 per cent Dextrose) by Janssen Pharmaceuticals, Inc.
It has an estimated market size of USD 46 million for the twelve months ending December 2015 according to IMS, the company said.
Levaquinis is used to treat bacterial infections that cause bronchitis or pneumonia and to treat people who have been exposed to anthrax or plague.
This approval is the 25th ANDA (including two tentative approvals) to be approved out of Unit-IV formulation facility in Hyderabad, India, used for manufacturing general injectable products.
Aurobindo Pharma's product range cover over six major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and Anti-Allergies. It is marketing these products globally in over 150 countries.
The approval is for Levofloxacin in 5 per cent Dextrose injection in the strengths of 250 mg/50 ml, 500 mg/100 ml, and 750 mg/150 ml, single use containers, Aurobindo Pharma said in a BSE filing.
The product is expected to be launched in the first quarter of 2016-17, it added.
The approved product is bio-equivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin (Levaquin in 5 per cent Dextrose) by Janssen Pharmaceuticals, Inc.
It has an estimated market size of USD 46 million for the twelve months ending December 2015 according to IMS, the company said.
Levaquinis is used to treat bacterial infections that cause bronchitis or pneumonia and to treat people who have been exposed to anthrax or plague.
This approval is the 25th ANDA (including two tentative approvals) to be approved out of Unit-IV formulation facility in Hyderabad, India, used for manufacturing general injectable products.
Aurobindo Pharma's product range cover over six major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and Anti-Allergies. It is marketing these products globally in over 150 countries.
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